NCT03810027

Brief Summary

Nocturnal polyuria may decrease the treatment efficacy of overactive bladder syndrome (OAB); and adjuvant medication, such as desmopressin, may be needed for the treatment of nocturnal polyuria. The knowledge of prevalence and risk factors of nocturnal polyuria might be important for the treatment of OAB. Thus, our aim is to describe the prevalence and risk factors of nocturnal polyuria in women with OAB.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,071

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
Last Updated

January 18, 2019

Status Verified

December 1, 2018

Enrollment Period

8.6 years

First QC Date

January 9, 2019

Last Update Submit

January 17, 2019

Conditions

Keywords

Nocturnal polyuriaOveractive bladder

Outcome Measures

Primary Outcomes (1)

  • Nocturnal polyuria

    Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women.

    Between July 2009 and January 2018

Study Arms (2)

OAB with nocturnal polyuria

The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women. Precence of nocturnal polyuria will be classified in this group.

Diagnostic Test: Bladder diary

OAB without nocturnal polyuria

The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for \<65 year-old women. Absence of nocturnal polyuria will be classified in this group.

Diagnostic Test: Bladder diary

Interventions

Bladder diaryDIAGNOSTIC_TEST

3-day bladder diary

OAB with nocturnal polyuriaOAB without nocturnal polyuria

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between July 2009 and January 2018, all women elder than 20-year-old with OAB visiting a medical center for evaluation were enrolled.

You may qualify if:

  • More than 20-year-old
  • Female
  • Diagnosed with overactive bladder

You may not qualify if:

  • Younger than 20-year-old
  • Pregnant or planned to be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

    PMID: 19941278BACKGROUND
  • Powell LC, Szabo SM, Walker D, Gooch K. The economic burden of overactive bladder in the United States: A systematic literature review. Neurourol Urodyn. 2018 Apr;37(4):1241-1249. doi: 10.1002/nau.23477. Epub 2018 Jan 13.

    PMID: 29331047BACKGROUND
  • Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.

    PMID: 24456314BACKGROUND
  • Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.

    PMID: 24007713BACKGROUND
  • Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.

    PMID: 12811491BACKGROUND
  • Onukwugha E, Zuckerman IH, McNally D, Coyne KS, Vats V, Mullins CD. The total economic burden of overactive bladder in the United States: a disease-specific approach. Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7.

    PMID: 19355803BACKGROUND
  • Coyne KS, Sexton CC, Bell JA, Thompson CL, Dmochowski R, Bavendam T, Chen CI, Quentin Clemens J. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013 Mar;32(3):230-7. doi: 10.1002/nau.22295. Epub 2012 Jul 27.

    PMID: 22847394BACKGROUND

MeSH Terms

Conditions

NocturiaUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ho-Hsiung Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 18, 2019

Study Start

July 1, 2009

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

January 18, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share